Description

Bupivacaine Ep Impurity C is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the anesthetic drug Bupivacaine by accurately identifying and quantifying process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and fine chemical industries who require reliable reference standards for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Bupivacaine Ep Impurity C in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies of Bupivacaine to understand degradation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry R&D to study impurity formation mechanisms and optimize purification processes.

Basic Information

Product Name	Bupivacaine Ep Impurity C
CAS No.	1797894-80-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine EP Impurity C; Bupivacaine Related Compound C; 1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Impurity; (2R)-1-Butyl-2-piperidinecarboxylic Acid 2,6-Dimethylanilide Impurity; Bupivacaine Process Impurity C; Bupivacaine Specified Impurity C
EINECS	Contact for details

Quality Control

Our Bupivacaine Ep Impurity C is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A(R2) and Q3B(R2) guidelines. Our commitment to traceability, stability, and data integrity supports your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.